Raloxifene Teva

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raloxifene

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR) for Raloxifene Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Raloxifene Teva.

This EPAR was last updated on 09/04/2019

Authorisation details

Product details
Name
Raloxifene Teva
Agency product number
EMEA/H/C/001075
Active substance
raloxifene hydrochloride
International non-proprietary name (INN) or common name
raloxifene
Therapeutic area (MeSH)
Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
G03XC01
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
29/04/2010
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

20/11/2018 Raloxifene Teva - EMEA/H/C/001075 - N/0024

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Assessment history

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